Suppliers and packagers for generic pharmaceutical drug: IVOSIDENIB

IVOSIDENIB

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192	NDA	Servier Pharmaceutical LLC	72694-617-60	1 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2021-10-19

Comprehensive Analysis of Ivosidenib Suppliers in the Pharmaceutical Industry

Last updated: April 23, 2025

Ivosidenib, a targeted therapy for cancers with IDH1 mutations, has established a complex global supply chain involving specialized manufacturers, distributors, and licensing partners. This report examines the key players in its production and distribution, regulatory frameworks, and market dynamics, providing a detailed overview of the ecosystem supporting this critical oncology drug.

Ivosidenib API Manufacturing Landscape

Major Active Pharmaceutical Ingredient (API) Producers

The production of ivosidenib API involves a network of certified manufacturers adhering to Good Manufacturing Practices (GMP). TAPI Technology & API Services, headquartered in Israel, stands out as a leading global supplier with over 350 API products, including ivosidenib[3][9][12]. The company’s expertise in customized CDMO solutions ensures compliance with international standards, particularly for the U.S. market via its USDMF (Drug Master File)[12]. Alembic Pharmaceuticals Limited, based in India, contributes to the supply chain with a vertically integrated approach, spanning API development to finished formulations[3][9]. Their DMF filings (No. 36786 and 36151) underscore their regulatory readiness for U.S. and European markets[9].

In China, Shanghai Hope Chem specializes in intermediates and APIs, offering competitive pricing influenced by regional market conditions[3][6]. Meanwhile, Teva Pharmaceutical Industries in Israel provides additional manufacturing capacity, supported by robust DMF documentation[9]. These manufacturers collectively address the demand for ivosidenib API, which fluctuates based on clinical guidelines and patent expirations[4][14].

Regulatory and Quality Assurance Frameworks

API suppliers must navigate stringent regulatory requirements. The U.S. FDA mandates USDMF submissions detailing chemical properties, manufacturing processes, and storage protocols[9][14]. For example, TAPI’s ivosidenib USDMF includes data on hydrolysis and CYP3A4-mediated metabolism, critical for batch consistency[14]. The European Medicines Agency (EMA) similarly requires ASMF (Active Substance Master File) compliance, ensuring alignment with ICH Q7 guidelines[10][14]. Certifications such as CEP (Certification of Suitability to the Monograph of the European Pharmacopoeia) further validate quality for EU markets[6][10].

Distribution Channels and Specialty Pharmacy Networks

Specialty Distributors

Ivosidenib’s distribution is tightly controlled through authorized partners. McKesson Specialty Health and Cardinal Health dominate the U.S. network, delivering the drug directly to hospital and office-based pharmacies[1][5][7]. These distributors manage cold-chain logistics and inventory for the 250 mg tablets, identifiable by their NDC codes (72694-617-60 for 10-digit, 72694-0617-60 for 11-digit)[1][7]. In Puerto Rico, Cardinal Health’s subsidiary ensures regional accessibility[1].

Specialty Pharmacies and Patient Support

Biologics by McKesson serves as a pivotal specialty pharmacy, shipping ivosidenib to patients’ homes since its FDA approval in 2018[5][7]. The ServierONE program complements this by offering insurance navigation, copay assistance, and adherence support, reducing out-of-pocket costs for eligible patients[1][4]. This dual distribution model—direct pharmacy access and home delivery—optimizes treatment continuity for acute myeloid leukemia (AML) and cholangiocarcinoma patients[1][5].

Licensing Agreements and Global Commercialization

Servier Pharmaceuticals’ Acquisition

Originally developed by Agios Pharmaceuticals, ivosidenib’s global rights were acquired by Servier in 2022, expanding its oncology portfolio[4][8]. Servier now oversees U.S. commercialization, while CStone Pharmaceuticals holds exclusive rights in Mainland China, Taiwan, Hong Kong, Macau, and Singapore[2][8]. The partnership includes milestone payments up to $412 million, reflecting the drug’s strategic value in Asian markets[8].

Patent Protections and Market Exclusivity

Ivosidenib benefits from multiple patents expiring between 2033 and 2039[4]. The earliest (January 2033) covers IDH1 mutation targeting, while later patents protect specific dosing regimens for cholangiocarcinoma[4]. These exclusivities shield the drug from generic competition, though API suppliers like Alembic and Teva are positioning themselves for post-patent opportunities[9][14].

Market Dynamics and Pricing Considerations

API Pricing Variability

The cost of ivosidenib API fluctuates based on production scale, regulatory audits, and raw material availability. For instance, Shanghai Hope Chem’s pricing reflects China’s lower labor costs, whereas TAPI’s offerings are premium-priced due to USDMF compliance[3][6][12]. PharmaCompass estimates volatility of ±15% annually, influenced by FDA inspections and generic entry timelines[6][14].

Regional Demand Patterns

In the U.S., ivosidenib’s adoption is driven by AML incidence (~20,000 new cases/year) and biomarker testing rates[4][11]. Europe’s demand hinges on EMA approvals for expanded indications, while Asia-Pacific growth correlates with CStone’s commercialization efforts in hepatobiliary cancers[2][8]. Emerging markets face access barriers due to cold-chain requirements and reimbursement challenges[1][10].

Challenges and Future Directions

Supply Chain Risks

API production remains vulnerable to geopolitical disruptions, as seen in Israel-based TAPI’s operational risks amid regional instability[12]. Additionally, USPTO patent challenges could accelerate generic entry, pressuring incumbent suppliers to optimize costs[4][14].

Innovation in Formulation

Next-generation IDH1 inhibitors in clinical trials (e.g., vorasidenib) may reshape supplier strategies. Manufacturers with dual-capacity APIs, like Alembic, are likely to pivot toward combination therapies requiring ivosidenib-based regimens[3][9].

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Key Takeaways

1. Ivosidenib’s API supply is dominated by TAPI, Alembic, and Teva, with rigorous USDMF/ASMF compliance.
2. Distribution through McKesson and Cardinal Health ensures targeted delivery to oncology centers.
3. Servier’s ownership and CStone’s Asian licensing drive global market penetration.
4. Patent expirations post-2033 will catalyze generic API production.
5. Pricing remains sensitive to regulatory audits and regional demand fluctuations.

FAQs

1. Which companies manufacture ivosidenib API?
   TAPI Technology, Alembic Pharmaceuticals, and Teva are key suppliers[3][9][12].

2. How is ivosidenib distributed in the U.S.?
   Specialty distributors like McKesson and pharmacies like Biologics handle logistics[1][5].

3. What financial assistance is available for patients?
   ServierONE offers copay support and insurance navigation[1][4].

4. When will generics enter the market?
   Post-2033, following patent expirations[4][14].

5. Which regions does CStone Pharmaceuticals cover?
   Mainland China, Taiwan, Hong Kong, Macau, and Singapore[2][8].

“Specialty distributors like McKesson ensure that TIBSOVO reaches patients efficiently, whether through hospital pharmacies or direct home delivery.” – Servier Pharmaceuticals[1]

References

1. https://www.tibsovopro.com/cca/access
2. https://servier.us/blog/servier-announces-fda-approval-of-tibsovo-ivosidenib-tablets-for-the-treatment-of-idh1-mutated-relapsed-or-refractory-r-r-myelodysplastic-syndromes-mds/
3. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ivosidenib
4. https://oncodaily.com/drugs/ivosidenib-overview
5. https://www.mckesson.com/about-mckesson/newsroom/press-releases/2018/tibsovo-idh1-inhibitor-available-for-order-at-biologics-inc/
6. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ivosidenib
7. https://biologics.mckesson.com/tibsovo-ivosidenib-an-idh1-inhibitor-approved-for-treatment-of-relapsed-refractory-acute-myeloid-leukemia-with-an-idh1-mutation-available-for-order-at-biologics-by-mckesson/
8. https://pmc.ncbi.nlm.nih.gov/articles/PMC6315051/
9. https://www.pharmacompass.com/us-drug-master-files-dmfs/ivosidenib
10. https://pharmaoffer.com/api-excipient-supplier/enzyme-replacements-modifiers/ivosidenib
11. https://pubchem.ncbi.nlm.nih.gov/compound/Ivosidenib
12. https://pharmaoffer.com/api-excipient-supplier/company/tapi/product/ivosidenib
13. https://zuviuslifesciences.in/api/
14. https://www.pharmacompass.com/active-pharmaceutical-ingredients/ivosidenib